MINIPRIN

Dosage form: tablet, coated
Ingredients: ASPIRIN 81mg
Labeler: TIME CAP LABORATORIES, INC
NDC Code: 49483-054

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

In each tablets Aspirin 81 mg (NSAID*)

PAIN RELIEVER

INDICATIONS AND USAGE:

Pain Reliever – temporarily relieves minor aches and pains.  For other uses, see your doctor. Do not use for more than 10 days without consulting your doctor because serious side effects may occur.

WARNINGS: 
Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product.  When using this product,, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. 

Allergy alert:  Aspirin may cause a severe allergic reaction, which may include: facial swelling, shock, hives, asthma (wheezing)

Stomach bleeding warning:  This product contains an NSAID, which may cause severe stomach bleeding.  The chance is higher if you are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinning (anticoagulant) or steroid drug, take other drugs containing prescription or nonprescription NSAIDS(aspirin, ibuprofen, naproxen or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed.

DOSAGE AND ADMINISTRATION:

Drink a full glass of water with each dose.  Adults and children 12 years and over; take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor.  Children under 12 years; consult a doctor.

acetylated monoglycerides, anhydrous lactose, colloidal silicon dioxice, croscarmellose sodium, D-CYellow no.10 aluminum lake, hypromellose, hypromellose phthalate, iron oxide yellow (iron oxide ochre), microcrystalline cellulose, mineral oil, polyethylene glycol (PEG) 80, titantium dioxide

Keep Out of the Reach of Children:   In case of overdose, get medical help or contact a Poison Control Center right away

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MINIPRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-054
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
DIACETYLATED MONOGLYCERIDES 
ANHYDROUS LACTOSE 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
HYPROMELLOSES 
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) 
FERRIC OXIDE YELLOW 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
POLYETHYLENE GLYCOL 400 
POLYSORBATE 80 
TITANIUM DIOXIDE 
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize7mm
FlavorImprint Code8
Contains    
Packaging
#Item CodePackage Description
1NDC:49483-054-12120 TABLET, COATED (TABLET) in 1 BOTTLE, PLASTIC
2NDC:49483-054-101000 TABLET, COATED (TABLET) in 1 BOTTLE, PLASTIC
3NDC:49483-054-00100000 TABLET, COATED (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34305/07/2012
Labeler - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIOperations
TIME CAP LABORATORIES, INC037052099manufacture

Revised: 05/2012
 
TIME CAP LABORATORIES, INC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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